FDA Rule Change Would Allow Generics To Update Labels

In June, 2011, the United States Supreme Court ruled in Pliva, Inc. v. Mensing that a generic drug manufacturer could not be liable for failing to warn of injuries as a result of taking a generic version of a name-brand drug. The court said that was because generic drug manufacturers are not permitted to make any changes to the labeling for name-brand drugs.

The U.S. Food and Drug Administration (FDA) recently proposed a major new rule that would allow generic drug manufacturers to independently change their labeling if the companies become aware of a dangerous propensity of their drugs. The current FDA regulations require generic manufacturers to notify the FDA and the brand name manufacturer of proposed label changes and wait until the brand name label change has been approved. The proposed changes would allow both brand and generic manufacturers to use the Changes Being Effected (CBE) process to add new warnings to their drug labels. The proposed regulations would also require generic manufacturers to update their labels within 30 days to conform to a label change made by the manufacturer of the name-brand drug. They are now only required to do so “as soon as possible.”

More than 80 percent of prescriptions filled in the U.S. are for generics. Based on Mensing, a person injured by a generic drug cannot sue a generic drug manufacturer, no matter how severely injured or how bad the manufacturer’s conduct was. The new regulations would allow consumers harmed by a generic drug to have their day in court when a generic manufacturer puts a defective product on the market with no warning of a known hazard or danger. If you need more information on this subject, contact Melissa Prickett, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.